An open label study to evaluate the Anti-Acne potential of the Kogigold cream in reduction of inflammatory and non-inflammatory acne lesion on oily & or mixed skin types of volunteers.â€.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- 1. Mean percent change from baseline to week 4 in the inflammatory (papules and pustules) lesion count
研究概览
简要总结
An open label study to evaluate the Anti-Acne potential of Kogigold cream in reduction in the inflammatory and non-inflammatory lesion count on face.
Following provision of informed consent and completion of all screening assessments, eligible subjects will be enrolled in the study.
Study will be conducted over a period of 28 days for each subject, subject will apply anti acne cream twice daily with the gap of 6-8 hours between two successive applications, till the investigator inform subject to stop application or the study ends for the maximum period of 28 days.
Subject will apply Anti Acne cream on full face, facial skin will be evaluated by Dermatologists for reduction in Total Lesion Count (TLC) on day 1, 7, 14, 21 & Day 28.
Safety Assessment- for any signs of irritation (redness/inflammation, itching or irritation).
Subjects will be assessed for frequency and severity of adverse events
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female subjects aged 18 to 45 with mild to moderate Acne Vulgaris.
- •Acne on the face, either non-inflammatory lesions (i.e., open and closed comedones) AND inflammatory lesions (i.e., papules and pustules).
- •Subjects with facial acne having IGA grade 1 and 2
- •Subjects with Oily & or Mixed type of facial skin.
- •Good general and mental health with, in the opinion of the investigator or medically qualified designee with no clinically significant and relevant abnormalities in medical history or upon physical examination
- •Willingness to participate as evidenced by voluntary written informed consent
- •Subject are willing to comply with study instructions and return to the clinic for required visits.
排除标准
- •Subject is pregnant, lactating, or is planning to become pregnant during the study.
- •Subject has any skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical or systemic therapy
- •Subject has greater than two (2) facial nodules.
- •Subject has nodulocystic acne
- •Subject is currently enrolled in an investigational drug or device study OR has been treated with an investigational product or device within 30 days prior to the initiation of treatment (Baseline)
- •Subject has facial hair especially full-grown beard that could interfere with the study assessments in the opinion of the investigator.
- •Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.
- •Subject has used any of the prohibited topical anti-acne treatments or procedures prior to the study unless appropriate washout period is documented.
- •Patients exhibiting acute or chronic dermatological, medical, and/or physical conditions which would preclude application of the test materials and/or influence the outcome of the study.
- •Patients who must use oral corticosteroids and/or oral immunosuppressive drugs (steroid inhalers or decongestant nose drops and/or eye drops are permitted).
- •Active dermatosis (local or disseminated) that might interfere with the results of the study.
- •History of diseases aggravated or triggered by ultraviolet radiation.
- •Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30days of the screening visit.
结局指标
主要结局
1. Mean percent change from baseline to week 4 in the inflammatory (papules and pustules) lesion count
时间窗: Day 1, Day 7, Day 14, Day 21, and Day 28
2. Mean percent change from baseline to week 4 in the Non-inflammatory (open and closed comedones) lesion count.
时间窗: Day 1, Day 7, Day 14, Day 21, and Day 28
次要结局
- 1) Mean percent change from baseline to week 2/(D-14) in the inflammatory (papules and pustules) lesion count(2) Mean percent change from baseline to week 2/(D-14) in the Non-inflammatory (open and closed comedones) lesion count.)
研究者
Dr Shendkar Sonal Mahadev
Skinovate Laser and Cosmetic Surgery center